Autologous CD22 CAR T Cells Following Commercial CD19 CAR T Cells in B Cell Malignancies

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT06408194
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
1 Year - 25 Years
Healthy Volunteers
Not accepted

Interventions

  • CD22CART infusion — DRUG
    CD22CART will be administered after Standard of Care (SOC) administration of tisagenlecleucel.
  • Tisagenlecleucel — DRUG
    All enrolled participants will receive lymphodepletion followed by standard of care tisagenlecleucel infusion.

Study Details

The primary purpose of this study is to determine safety, feasibility, and the Maximum Tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) of CD22 Chimeric Antigen Receptor T-Cell Therapy (CART) cells when administered 28 to 42 days after an infusion of a commercial CAR called Tisagenlecleucel, to children and young adults with relapsed or refractory B-cell leukemia.

Key Dates

Start date
May 13, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lymphodepletion
    All enrolled participants will receive lymphodepletion followed by standard of care tisagenlecleucel infusion.

Primary Outcome Measure

The number of patients who experience dose limiting toxicities (Phase 1) [ Time Frame: 28 days after single infusion of CD22 CAR T cells ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304
Michelle Fujimoto
[email protected]
650-736-0539
Kara L Davis, DO (PRINCIPAL_INVESTIGATOR)

Find similar trials in Palo Alto, CA

By condition
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By specialty
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By research site
Stanford University· Palo Alto, CA

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